Stethoscope: Time for the politics of the Covid-19 vaccine to catch up

This article first appeared in Forum, The Edge Malaysia Weekly, on July 27, 2020 - August 02, 2020.
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On July 21, the world was treated to good news in the search for a Covid-19 vaccine. Phase 2 clinical trials by the Beijing Institute of Biotechnology and the University of Oxford separately showed that more than 90% of subjects developed neutralising antibodies to Covid-19. The clinical trials relied on partnerships with pharmaceuticals CanSino Biologics and AstraZeneca respectively. The science is progressing much faster than we expected. It is time for the politics of the Covid-19 vaccine to catch up.

The rapid progress for a Covid-19 vaccine was not always guaranteed. Despite bitter recent experience, the world does not have an effective vaccine against the coronavirus family of viruses, which includes SARS, MERS-CoV and Covid-19. The vaccine discovery process is inherently technically difficult and slow, often taking 5 to 10 years.

The different vaccine approaches (inactivated, attenuated, sub-unit, viral vector, RNA or DNA vaccines) engender passionate and esoteric debates between virologists and researchers. Our understanding of Covid-19 continues to evolve. All these created a cautious mood among scientists, bordering on pessimism.

Fortunately, there were silver linings during Covid-19 that were not present during the SARS and MERS outbreaks. The sheer scale of Covid-19 meant that a lot more funding, political energy and scientific attentions were ploughed into Covid-19 compared with SARS in 2003 and MERS in 2014. Science today is more sophisticated than just five years ago, and scientific collaboration between universities and between countries is much more constructive today.

Additionally, there have been positive experiences with public-private partnerships globally, especially with cutting-edge biopharmaceuticals, allowing for the best brains to work together. There was a fear in the beginning of Covid-19 that researchers will engage in destructive competition in the race to be the first vaccine, but instead there have been transparency, a spirit of collaboration and a sense of joint purpose.

At the time of writing, the world had about 160 vaccine candidates in various stages of testing. Humanity can be proud of how science has rallied and progressed at an unprecedented pace. However, we now have other non-science hurdles to overcome.


From one laboratory to a million clinics worldwide

There are still several months until the Beijing or Oxford vaccines complete their Phase 3 trials. We must use that time to prepare the solutions for other hurdles, simultaneously. The first among these is regulatory. The process of approving and registering medicines and vaccines during “peacetime” is understandably laborious and exacting, because human lives are at stake.

Although these high standards must be equally applied to a Covid-19 vaccine, the sheer scale of it might mean that we need “wartime” approval standards that balance speed with rigour. An additional complexity is that the world’s regulatory agencies have different levels of competence. Many countries are reliant on the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) to conduct the assessments, which mean that the fate of many countries is partially dependent on these two agencies.

That is why countries must spend the next few months discussing how they will expedite the approval of a Covid-19 vaccine in a way that balances speed and rigorous evidence.

The second hurdle would be patents. There is an ongoing discussion about Covid-19 technologies being global public goods, and that discussion must now actively discuss the implications on intellectual property laws under the World Trade Organization. In advance of an acceptable consensus, pharmaceutical companies like Gilead have issued a voluntary licence to 127 countries worldwide for Remdesivir, a medicine with some modest effect in treating Covid-19.

That is not enough. The world must use the next few months to actively discuss the specific legal instruments and interpretations that err on the side of saving lives. These discussions and solutions must be agreed upon now, because they are often contentious, invoke the spectre of neo-colonialism when rich countries (or companies) decide for poor countries, and create legitimate concerns about the rampant profiteering of out-of-control capitalism.

The third hurdle is manufacturing 7.5 billion doses as quickly as possible. Already, we see the UK pre-ordering 100 million doses of the Oxford/AstraZeneca vaccine, even though its population is only 65 million. This is on top of the aggressively nationalistic behaviour of countries like the US who commandeered medical equipment during Covid-19.

Unfortunately, this is understandable from a political science perspective. The first duty of any government is to its citizens, not to the world. Therefore, it is unfortunate that Homo sapiens met Covid-19 at a time when the world is (still) arranged by self-interested nation states.

One way to overcome this nationalistic behaviour is to spend the next six months rapidly building surge manufacturing capacity. The more vaccine factories we can build in the next six months means we can produce more vaccines. That will mean that we can make better choices and be less competitive with other countries.

The final hurdle is distribution. The logistics, cold chain, temperature control, preventing theft and tampering and last mile delivery to all corners of all countries is already daunting enough. Equitable distribution is the far bigger challenge.

The Coalition for Epidemic Preparedness Innovations (CEPI) is a global partnership of more than 150 countries that has the clearest commitment to equitable distribution. In their COVAX Facility, all countries will receive vaccines for 20% of their population in the first wave of production. How each country chooses to distribute that 20% “first wave quota” is up to them.

This is a good starting point for discussion. There are other elements to consider, such as whether COVAX is legally binding, safeguards against seizures or commandeering, and penalties for non-compliance.


How can Malaysia prepare for the vaccine?

I propose three strategies for Malaysia in the coming months. We must not waste the next 6 to 12 months, as preparing the political, economic and social contract landscape for the vaccine is not easy.

The first strategy is to initiate a conversation on the appropriate review process within the National Pharmaceutical Regulatory Agency (NPRA), the body that approves the medicines and vaccines for Malaysia. Currently, the priority review process is already 100 working days (about five calendar months). While I am not blindly advocating for speed over rigour, discussions on the appropriate balance between speed and rigour can be started now.

The NPRA is an excellent agency, operating with high competence and integrity. They can lead the conversation on the appropriate review process given the unprecedented nature of Covid-19. That conversation can include regulatory experts, lawyers, pharmaceutical industry professionals and ethicists, where necessary.

The NPRA can also build a Covid-19-specific network with regional peers like the Health Sciences Authority of Singapore (HSA) and the Drug Control Division in Thailand. In recent years, there has been useful rhetoric on pharmaceutical regulatory harmonisation in Asean and some implementation. The urgency and scale of Covid-19 means that existing Asean infrastructure (like the Asean Common Technical Document approach) can be leveraged and accelerated.

Given the lean resources of Southeast Asian drug regulators, they can share some expertise or divide up the workload in the regulatory assessment of Covid-19 vaccines. These discussions should begin now.

The second strategy is to rapidly increase Malaysia’s domestic pharmaceutical manufacturing capacity. As Malaysia is very late to the Covid-19 vaccine research game (and without domestic historical expertise or success in vaccine research), we should not commit funds to research.

Instead, a more realistic alternative is to scale up our factories. Minister of Science, Technology and Innovation Khairy Jamaluddin had it right when he identified two local companies to provide “fill and finish” functions for the Covid-19 vaccine when it is ready. We can build on this by exploring the possibility of local factories producing the vaccines from start to finish.

There is an opportunity for Malaysian factories to fulfil the entire production chain of vaccines. Instead of relatively low-skill and low-tech bottling, we can manufacture the active ingredients, antigens, additives and adjuvants, and then combine and bottle them while meeting good manufacturing practices.

Not only will we achieve “vaccine sovereignty” for ourselves, we are also going up the manufacturing value chain. We can also export to our Southeast Asian neighbours who might not be able to produce vaccines domestically.

The third strategy is to get Malaysia a seat and a louder voice at the global health decision-making table. This requires health diplomacy and a smart hand in our global narrative. By most accounts, Malaysia has done well in our Covid-19 responses, and this provides two advantages. One, we now have the luxury of shifting our attention to the politics of global health and how it impacts us. Two, people will listen to our voice when we speak.

The voice of middle-income countries like Malaysia and Southeast Asia is crucially missing in global health (or at least in the meetings that I attended). The high-income countries usually dictate the agenda, and the needs of the low-income countries are often discussed; middle-income countries are too rich to need help, but not rich enough to sustainably deliver healthcare. Let’s call it the “sandwich problem”. Southeast Asia is also “sandwiched” between billion-people India and China and easily forgotten in favour of the East Asian tiger economies and Australia.

If Malaysia were to get a louder voice in global health decision-making, it will help us shape the discussions around vaccines and protect our own health security, while assisting our neighbours. That voice is a crucial voice, especially as the discourse around global health begins to be decolonised and diversified.

We have bought ourselves some time with our relatively good response to Covid-19 thus far. That luxury of time must also be translated into meaningful preparation for the vaccine. We have bought that luxury through sacrifice; we must not waste the next few months.

Khor Swee Kheng is a physician specialising in health systems, health policies and global health

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